Open Positions: Senior Research Scientist/ Research Investigator, Analytical R&D
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
We are currently seeking an experienced analytical chemist to join the Analytical Research and Development organization within Technical Operations at Arvinas. The incumbent will serve as a core member of a multidisciplinary project team and directly impact execution of the analytical programs for both active pharmaceutical ingredient and drug product development and manufacturing. A key responsibility of this role will be program oversight of the associated CDMOs. The qualified individual will have a track record of accomplishment in analytical method development, conducting complex analytical investigations along with CDMO oversight. This position reports to our Director of Analytical R&D and will work closely with the members of Chemical Process Development, Formulation R&D, and External Manufacturing and Supply. In addition, the incumbent will work closely with project teams to develop and execute a streamlined program to advance assets into clinic and then into commercialization. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
This position is located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Conduct laboratory-based analytical investigations to trouble-shoot complex analytical problems using H/UPLC, LC/MS, NMR, DSC, TGA and PXRD.
- Provide technical oversight of contracted suppliers in execution of analytical-related deliverables, including phase-appropriate method development and validation.
- Manage, review analytical data and reports, track release, stability, and reference material testing, and lead laboratory investigations along with QA. Analyze stability trends through statistical and scientific tools.
- Working with External Supply and Manufacturing, craft the relevant technical sections of RFPs to commission analytical development and investigations at CDMOs.
- Evaluate proposals for technical content matching the capabilities of the supplier with the project requirements.
- Working with External Manufacturing and Supply select the best providers of service to meet project needs.
- Ensure that validation work and testing are conducted in a manner compliant with cGMPs and regulatory requirements
- Facilitate the collection of relevant analytical data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.
- Provide management of in-house analytical instruments.
- Evaluate quotes from vendors and recommend instrument acquisition as subject expert.
- Communicate analytical workplans and strategies with functional group leaders to ensure project timelines are met.
- A Ph.D or M.S. in Chemistry or related technical field and 5-10 years of relevant experience in analytical development in the pharmaceutical or bio-tech environment.
- A successful history of hands-on analytical investigations and method development encompassing chromatography, spectroscopy, NMR, and mass spectrometery. Experience with solid state analysis is a plus.
- A competent grasp of organic chemistry and functional group reactivity.
- A solid understanding of chemical process development and formulation development
- A successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors.
- Experience with analytical deliverables of in all stages of API and DP development and manufacturing.
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to manufacture and quality testing of pharmaceutical products.
- Experience in contributing to and review of regulatory submissions
- Ability to effectively prioritize and deliver on tight timelines
- Outstanding problem-solving abilities
- Detail-oriented, with good organizational and project management skills
- Good oral and written communications skills
- Proficient with MS Word, PowerPoint, Excel
- Strong project planning, and presentation skills
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal and external project partners
- Ability to be proactive in identifying issues and hurdles that may hinder the effective progression of an asset and resolve the issues in a timely and creative fashion
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.